Senior Validation Specialist
2 days ago
About CAI
CAI is a 100% employee-owned company with a strong commitment to safety, quality, and customer satisfaction. Our team of experts provides commissioning, qualification, validation, start-up, project management, and consulting services to FDA-regulated industries.
Our Approach
We put the client's interests first and strive for excellence in everything we do. Our employees are owners, and as such, we take pride in our work and are committed to living our Foundational Principles: integrity, service to others, service to society, and working for our future.
Career Opportunities
We are seeking a highly skilled CQV Engineer to join our growing operations in Ireland. As a key member of our team, you will be responsible for conducting and leading Commissioning, Qualification, and Validation activities with a focus on safety.
Key Responsibilities
- Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
- Generate C&Q Procedures for projects
- Approve TOPs
- Facilitate scoping/planning of commissioning spares and consumables
- Deliver C&Q activities as required to meet the schedule
- Track progress of C&Q activities as required
- Prepare Qualification Summary Reports (QSR), and manage Requirement Traceability Matrix (RTM)
- Execute Design reviews, shakedown, commissioning, FAT's, IQ, OQ, PQ activities
- Manage any aspect of C & Q, verification as requested i.e., Change Controls, Management of Contractors and Vendors, document control, punch list management
- Coordinate with project contractors and equipment vendors to execute required tests
- Allocate project resources for efficient execution of project deliverables
- Coordinate support during C&Q execution
Requirements
- BS or MS in a relevant science or engineering field, or equivalent
- 3+ years in CQV SME roles for life sciences – Clean Utilities/Filling experience preferable
- Excellent oral and written communication skills
- Excellent problem-solving skills
- Customer-service focused
- Proficient in life science manufacturing processes in areas such as biotech, aseptic fill/finish, OSD, Gene Therapy or equivalent experience
- Able to travel domestically and internationally if required
-
Validation Specialist
1 day ago
Limerick, Limerick, Ireland TN Ireland Full timeAt TN Ireland, we are seeking a skilled Validation Specialist to join our team in Limerick.The ideal candidate will have a strong background in executing and cleaning validation protocols, as well as experience in writing and approving Deviations/GMP documents.A key responsibility of this role will be to generate, review, and approve SIP/CIP protocols,...
-
Cleaning Validation Specialist
3 weeks ago
Limerick, Limerick, Ireland CareerWise Recruitment Full timeJob Description CLEANING VALIDATION SPECIALIST with rinse & swab experience required by CareerWise Recruitment for our multinational BioTech client in Limerick, initial 12 month contract on offer.The CLEANING VALIDATION SPECIALIST will have experience in the execution of cleaning validation protocols, experience on writing and approving Deviations/ GMP...
-
Validation Specialist
4 weeks ago
Limerick, Limerick, Ireland Life Science Recruitment Full timeWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.DutiesExecute cycle development, cleaning validation and PQ of equipment.Writing and adhering to validation...
-
Validation Specialist
4 weeks ago
Limerick, Limerick, Ireland Life Science Recruitment Full timeWe're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.Duties1. Execute cycle development, cleaning validation and PQ of equipment.2. Writing and adhering to...
-
QA Validation Specialist
2 weeks ago
Limerick, Limerick, Ireland Hobson Prior Full timeHobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant...
-
Cleaning Validation Specialist
3 weeks ago
Limerick, Limerick, Ireland CareerWise Recruitment Full timeJob Description A Cleaning Validation Specialist is required by Careerwise recruitment to work with our Limerick based Biotechnology client. Role of this position Generates, executes and/or reviews master and completed cleaning validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other...
-
QA Validation Specialist
3 weeks ago
Limerick, Limerick, Ireland Hobson Prior International Ltd Full timeHobson Prior is collaborating with a Biotech company who are in search of a Specialist in QA Validation. The chosen individual will offer supervision for the production and distribution of Gene Therapy medicinal products. They will be instrumental in guaranteeing that processes and equipment meet validation and qualification standards as per relevant...
-
Senior Validation Lead
3 days ago
Limerick, Limerick, Ireland HERO Recruitment Full timeJob DescriptionIn this role, you will develop and execute Test Method Validations to ensure compliance with quality and regulatory standards.You will work closely with design, process, and quality teams to validate and implement manufacturing processes.Responsibilities Include:TMV Development: Develop and execute TMVs for test equipment, ensuring compliance...
-
Senior Validation Professional
2 days ago
Limerick, Limerick, Ireland NIRAS Ireland Full timeWe are looking for an experienced Senior Manufacturing Engineer who will be responsible for developing quality plans, managing new processes, and ensuring TMV closure for design and process functions.Responsibilities:Develop / Execute Test Method Validations for Test Equipment per current QMS/Regulatory standards.Validate and Implement Medical Device...
-
Senior Test Specialist
4 days ago
Limerick, Limerick, Ireland Software Placements Full timeAbout the RoleThe Senior Test Specialist will be responsible for defining long-term validation roadmaps, planning and executing test cases, and consulting on required hardware and software to automate testing. You will have a minimum of 5 years of experience in systems test engineering and/or formal testing of complex systems.
-
Validation Specialist
6 days ago
Limerick, Limerick, Ireland TN Ireland Full timeJob TitleTechnical Writer Cleaning ValidationAbout the RoleTN Ireland is seeking an experienced Technical Writer to work on a major expansion project in the Munster region. The successful candidate will be responsible for managing a large program, generating/reviewing/approving SIP protocols, and maintaining/updating the Cleaning/SIP Validation Plan.Key...
-
QA Validation CSV Specialist-(Multi Level)
2 weeks ago
Limerick, Limerick, Ireland Regeneron Ireland DAC Full timeWorking under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...
-
Qa Validation Csv Specialist-(Multi Level)
6 days ago
Limerick, Limerick, Ireland Regeneron Ireland Dac Full timeWorking under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations.The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...
-
Qa Validation Csv Specialist-(Multi Level)
3 days ago
Limerick, Limerick, Ireland Regeneron Ireland Dac Full timeWorking under the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations.The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal...
-
Strategic Remediation Validation
23 hours ago
Limerick, Limerick, Ireland Northern Trust Full timeStrategic Remediation Validation - Financial Risk SpecialistAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals,...
-
Senior Validation and CSV Engineer
4 weeks ago
Limerick, Limerick, Ireland Cpl Healthcare Full timeSenior Validation & CSV EngineerThis person is responsible for leading validation teams' efforts for systems and processes to ensure compliance with industry standards and regulatory requirements. This role involves leading validation activities, developing validation strategies, executing test plans, analyzing data, and providing technical expertise to...
-
Senior Quality Control Specialist
4 days ago
Limerick, Limerick, Ireland Regeneron Ireland DAC Full timeAbout This RoleWe are seeking a highly skilled Senior Quality Control Specialist to join our team. In this role, you will be responsible for performing assay transfers, validation, and investigation activities for QC.As a Senior Quality Control Specialist, your typical day might include:Performing assay validation for QCReviewing new test procedures and...
-
Strategic Remediation Validation
4 days ago
Limerick, Limerick, Ireland Northern Trust Full timeStrategic Remediation Validation - AML SpecialistAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and...
-
Pharmaceutical Validation Expert
6 days ago
Limerick, Limerick, Ireland Life Science Recruitment Full time**About the Role**We are seeking an experienced Validation Specialist to join our team at a leading pharmaceutical organization based in Ireland.The successful candidate will be responsible for executing cycle development, cleaning validation, and performance qualification of equipment. They will also write and adhere to validation strategies, coordinate...
-
Equipment Validation Professional
6 days ago
Limerick, Limerick, Ireland Life Science Recruitment Full time**Role Description**We're currently recruiting for a highly skilled Validation Specialist to join our team at a leading pharmaceutical organization based in Ireland.The successful candidate will be responsible for executing cycle development, cleaning validation, and performance qualification of equipment. They will also write and adhere to validation...